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November 16, 2021

FDA grants 510(k) clearance to GE’s AI algorithm for ETT placements

Critical Care Suite 2.0 automatically detects ETTs in chest x-ray images and displays an accurate measurement of tube positioning.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for GE Healthcare’s artificial intelligence (AI) algorithm that helps in assessing endotracheal tube (ETT) placements in chest x-ray images.

The algorithm is said to be one of five solutions included in the company’s Critical Care Suite 2.0.

This suite includes AI algorithms embedded on a mobile x-ray device to help radiologists prioritise critical cases and reduce review time by automating the process.

The company stated that the Critical Care Suite 2.0 automatically detects ETTs in chest x-ray images.

It is designed to display an accurate measurement of the tube positioning on the monitor of the x-ray system within seconds.

The measurements can be accessed and reviewed in picture archiving and communication systems (PACS). This will help in determining if the ETT is placed correctly or requires additional attention.

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Notably, inaccurate placement of ETT can trigger various complications, including a type of collapsed lung known as pneumothorax.

However, the Critical Care Suite 2.0 can issue an automated alert to radiologists for suspected pneumothorax cases. Additionally, an on-device notification is sent to the technologist regarding the prioritised cases.

Since November 2020, GE Healthcare has been distributing Critical Care Suite 2.0 under the FDA’s Covid-19 imaging guidance.

The company stated that the new clearance will allow the system to be used separately from the public health emergency.

GE Healthcare imaging president and CEO Jan Makela said: “At GE Healthcare, we saw the potential role of Critical Care Suite 2.0 in helping hospitals manage the crisis caused by the number of patients who needed ETT placements during the pandemic, requiring accelerated innovation, and we quickly worked with the FDA to make the solution available to clinicians.

“GE Healthcare is not only accelerating the development and access of new tools to help hospital staff keep up with demand, but also leading the way on Covid-era advancements that will transform the industry and have a long-lasting impact after the pandemic.”

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